Recruiting

Observational Study

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT04865081

Conditions

Intubation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

VACCIN box

Study Details

Brief summary:

The VACCIN box, an anti-aerosol intubation box for potential use on COVID-19 (SARS-CoV-2) positive patients, was designed in order to reduce the transmission risk to healthcare workers. This study will compare the safety and the ease of use of the VACCIN box to a standard intubation in healthy participants undergoing elective surgery. It is expected that intubation times and success rate of intubation in the same circumstances will be similar with and without the use of the VACCIN box.

Conditions

Intubation

Study ID

NCT04865081

Start date

Apr 19, 2021

Status verified date

Apr, 2021

Completion date

Jul, 2021

Anticipated

Primary completion date

Jun, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Elective surgery requiring general anesthesia with tracheal intubation
  • ASA status I, II or III
  • Good understanding of English or French

Exclusion Criteria:

  • Known difficult airway
  • Anticipated difficult airway (Mallampati ≥ 3, oral opening < 2.5 cm, thyromental distance < 6 cm, limited cervical mobility, significant abnormality of the upper respiratory tract, history of major surgery on airway or cervical area)
  • COVID-19 positive or unknown status
  • Rapid sequence contraindication
  • Presence of antibiotic-resistant bacteria requiring a form of additional protective equipment
  • Claustrophobia
  • Chronic anxiety
  • BMI ≥ 35
  • Allergy or intolerance to any of the study drugs
  • Emergent surgery
  • Pregnancy
  • Preoperative hemodynamic disturbance
  • Patient refusal

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: VACCIN box group

The anesthesiologist will intubate the participants in the VACCIN box group while using the VACCIN box that will be placed over the participants' head.

no intervention: Control group

Enrolled participants in the control group will be intubated without the use of the VACCIN intubation box (standard anesthesia).

Interventions

VACCIN box

The VACCIN box is a translucid box that can be placed over the patient's head. It has entry holes on the front and the side of the box in which nitrile gloves can be attached. The anesthesiologist can intubate with arms and hands inside the box. Its also has the capacity to create a negative pressure environment inside the box by connecting an air suction cable from the box to the OR medical aspiration line.

Primary outcome measure

  • Intubation time [ Time Frame: Intubation time will correspond to the time interval in seconds between the preoxygenation face mask removal and the detection of end-tidal CO2 on the anesthesia monitor ]

Central Contacts and Locations

Central contacts

Issam Tanoubi

514 252 3400i.tanoubi@umontreal.ca

Locations

Maisonneuve Rosemont Hospital

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Issam Tanoubi, MD

514 252 3400i.tanoubi@umontreal.ca

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Apr 29, 2021

Last verified

Apr, 2021

Keywords

  • videolaryngoscopy
  • intubation box
  • aerosol box
  • COVID-19

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2021-04-29.